Wounds and InjuriesLIFT-CNCT07882589
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
An observational study of Wounds and Injuries and Out-of-Hospital Cardiac Arrest, run by Azienda Usl di Bologna at 2 sites in Italy.
Trial summary
This retrospective population-based cohort study uses linked administrative healthcare data from the Local Health Authority of Bologna (Italy) to describe the use of four classes of psychoactive drugs (opioids, antiepileptics, antipsychotics, and antidepressants) after hospital discharge in two populations, adults… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Out-of-Hospital Cardiac Arrest, Traumatic Brain Injury
- What is being tested?
- Opioids (ATC N02A), Antiepileptics (ATC N03A) and Antipsychotics (ATC N05A)
- How many people
- 52,720 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Jun 2026to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult residents of the Local Health Authority of Bologna, Italy, discharged alive after (1) an urgent hospital admission for trauma between 2014 and 2024, or (2) a hospital admission following out-of-hospital cardiac arrest.
Who may be able to join
- Age 18 years or older
- Resident in the Local Health Authority of Bologna catchment area
- Trauma cohort: urgent ordinary-regime hospital admission with a discharge diagnosis in ICD-9-CM codes 800-999 and at least one injury with Abbreviated Injury Scale (AIS) severity of 1 or higher, between 2014 and 2024
- Cardiac arrest cohort: emergency department admission for out-of-hospital cardiac arrest with subsequent hospital discharge and ICD-9-CM code 427.5
- Residence and vital status confirmed on linkage to population records
Who cannot join
- Death in hospital or within one day after discharge
- Non-resident or vital status not confirmable
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Maggiore, Azienda USL di Bologna
Bologna, Emilia-Romagna, 40133
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
About this study
Official title: Long-Term Impact of Psychoactive Medications After Trauma and Cardiac Arrest: A Retrospective Cohort Study on Prevalence and Impact on Emergency Department and Hospital Readmissions
This retrospective population-based cohort study uses linked administrative healthcare data from the Local Health Authority of Bologna (Italy) to describe the use of four classes of psychoactive drugs (opioids, antiepileptics, antipsychotics, and antidepressants) after hospital discharge in two populations, adults admitted urgently for trauma and adults surviving out-of-hospital cardiac arrest, and to evaluate whether post-discharge exposure is associated with low-acuity or incomplete emergency department visits and urgent hospital readmissions within one year. Exposure is derived from outpatient dispensing records and classified as naive (started after discharge), long-term (before and after), or interrupted, and as current or not current over follow-up. Associations are estimated with marginal count regression models adjusted for demographics, illness or injury severity, and comorbidity, separately for each cohort.
Read the detailed description
Follow-up starts at the discharge ending the index care episode (including transfers or readmissions within one day) and continues until death, loss of eligibility, or one year. Dispensings are chained into treatment episodes using a 60-day grace period (30- and 90-day sensitivity analyses). Post-discharge exposure requires treatment initiation, continuation, or restart within 30 days of discharge; exposure states are assigned using only information available at each time point. Outcomes are counts of low-acuity or incomplete ED visits (missing, non-urgent, or minor-urgency discharge code; leaving before visit or record closure; or missing or ICD-9-CM V-code diagnosis) and urgent ordinary-regime hospital readmissions, excluding scheduled or routine contacts. Outcomes are analysed with marginal count regression models (negative binomial or Poisson, as appropriate) with patient-clustered robust standard errors, adjusted for sex, age, severity (New Injury Severity Score and body-region AIS for trauma), Charlson Comorbidity Index, and an early post-discharge period indicator.
- Being tested
- Opioids (ATC N02A), Antiepileptics (ATC N03A), Antipsychotics (ATC N05A), Antidepressants (ATC N06A)
- Keywords
- Opioids, Antidepressants, Antiepileptics, Antipsychotics, Deprescribing, Emergency Department, Patient Readmission, Pharmacoepidemiology
- Medical subject headings
- Wounds and Injuries, Out-of-Hospital Cardiac Arrest, Brain Injuries, Traumatic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioids (ATC N02A)Drug
Post-discharge outpatient dispensing of opioids (ATC N02A), as prescribed in routine care; exposure is observed, not assigned by the study.
Antiepileptics (ATC N03A)Drug
Post-discharge outpatient dispensing of antiepileptics (ATC N03A, including gabapentinoids and clonazepam), as prescribed in routine care; exposure is observed, not assigned by the study.
Antipsychotics (ATC N05A)Drug
Post-discharge outpatient dispensing of antipsychotics (ATC N05A), as prescribed in routine care; exposure is observed, not assigned by the study.
Antidepressants (ATC N06A)Drug
Post-discharge outpatient dispensing of antidepressants (ATC N06A), as prescribed in routine care; exposure is observed, not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| Trauma cohort | Adults resident in the Local Health Authority of Bologna discharged alive after an urgent ordinary-regime hospital admission for trauma (ICD-9-CM 800-999) between 2014 and 2024. Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records. Receives: Drug: Opioids (ATC N02A); Drug: Antiepileptics (ATC N03A); Drug: Antipsychotics (ATC N05A); Drug: Antidepressants (ATC N06A) | |
| Out-of-hospital cardiac arrest cohort | Adults resident in the Local Health Authority of Bologna admitted to the emergency department after out-of-hospital cardiac arrest and discharged alive from hospital (ICD-9-CM 427.5). Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records. Receives: Drug: Opioids (ATC N02A); Drug: Antiepileptics (ATC N03A); Drug: Antipsychotics (ATC N05A); Drug: Antidepressants (ATC N06A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Post-discharge Exposure to Each Psychoactive Drug Class
Percentage of patients with at least one qualifying post-discharge treatment episode (treatment initiation, continuation, or restart within 30 days of discharge) for each drug class: opioids (ATC N02A), antiepileptics (N03A), antipsychotics (N05A), and antidepressants (N06A), derived from outpatient dispensing records and reported separately for each cohort.
Measured: 1 year after hospital discharge
Percentage of Exposed Patients by User Type for Each Psychoactive Drug Class
Among patients exposed to each drug class (opioids, antiepileptics, antipsychotics, antidepressants) before admission and/or after discharge, percentage of naive users (exposure after discharge only), long-term users (exposure both before admission and after discharge), and interrupted users (exposure before admission only, not continued after discharge), reported separately for each cohort.
Measured: 1 year after hospital discharge
Percentage of New Users by Duration of Post-discharge Treatment for Each Psychoactive Drug Class
Among naive users of each drug class (opioids, antiepileptics, antipsychotics, antidepressants), percentage whose qualifying post-discharge treatment episode lasted up to 30 days, 31-90 days, or 91-365 days (episode span, with dispensings chained using a 60-day grace period), reported separately for each cohort.
Measured: 1 year after hospital discharge
Secondary outcomes (2)
Number of low-acuity or incomplete emergency department visits
Count of emergency department visits with a missing, non-urgent, or minor-urgency discharge severity code, with the patient leaving before the medical visit or before record closure, or with a missing or supplementary-classification (ICD-9-CM V code) diagnosis, excluding scheduled or routine contacts; analysed as incidence rate ratios by post-discharge exposure state.
Measured: 1 year after hospital discharge
Number of urgent hospital readmissions
Count of urgent ordinary-regime hospital admissions, excluding scheduled or routine contacts; analysed as incidence rate ratios by post-discharge exposure state.
Measured: 1 year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start10 Jun 2026
- Primary completion12 Aug 2026
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52,720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Sponsor
- Investigators
- Lorenzo Gamberini, Principal investigator, Azienda Usl di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882589
- Sponsor's protocol ID
- 195-2026-TESS-AUSLBO
- Acronym
- LIFT-C
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data derive from regional administrative health databases and cannot be shared under Italian and EU data protection regulations; aggregated data and analysis code are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Impact of Psychoactive Medications After Trauma and Cardiac Arrest: A Retrospective Cohort Study on Prevalence and Impact on Emergency Department and Hospital Readmissions
- ClinicalTrials.gov ID
- NCT07882589
- Acronym / sponsor ID
- LIFT-C / 195-2026-TESS-AUSLBO
- Keywords
- Opioids, Antidepressants, Antiepileptics, Antipsychotics, Deprescribing, Emergency Department, Patient Readmission, Pharmacoepidemiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52,720 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective population-based cohort study uses linked administrative healthcare data from the Local Health Authority of Bologna (Italy) to describe the use of four classes of psychoactive drugs (opioids, antiepileptics, antipsychotics, and antidepressants) after hospital discharge in two populations, adults admitted urgently for trauma and adults surviving out-of-hospital cardiac arrest, and to evaluate whether post-discharge exposure is associated with low-acuity or incomplete emergency department visits and urgent hospital readmissions within one year. Exposure is derived from outpatient dispensing records and classified as naive (started after discharge), long-term (before and after), or interrupted, and as current or not current over follow-up. Associations are estimated with marginal count regression models adjusted for demographics, illness or injury severity, and comorbidity, separately for each cohort.
Detailed description
Follow-up starts at the discharge ending the index care episode (including transfers or readmissions within one day) and continues until death, loss of eligibility, or one year. Dispensings are chained into treatment episodes using a 60-day grace period (30- and 90-day sensitivity analyses). Post-discharge exposure requires treatment initiation, continuation, or restart within 30 days of discharge; exposure states are assigned using only information available at each time point. Outcomes are counts of low-acuity or incomplete ED visits (missing, non-urgent, or minor-urgency discharge code; leaving before visit or record closure; or missing or ICD-9-CM V-code diagnosis) and urgent ordinary-regime hospital readmissions, excluding scheduled or routine contacts. Outcomes are analysed with marginal count regression models (negative binomial or Poisson, as appropriate) with patient-clustered robust standard errors, adjusted for sex, age, severity (New Injury Severity Score and body-region AIS for trauma), Charlson Comorbidity Index, and an early post-discharge period indicator.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma cohort | – | Drug: Opioids (ATC N02A), Drug: Antiepileptics (ATC N03A), Drug: Antipsychotics (ATC N05A), Drug: Antidepressants (ATC N06A)Adults resident in the Local Health Authority of Bologna discharged alive after an urgent ordinary-regime hospital admission for trauma (ICD-9-CM 800-999) between 2014 and 2024. Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records. |
| Out-of-hospital cardiac arrest cohort | – | Drug: Opioids (ATC N02A), Drug: Antiepileptics (ATC N03A), Drug: Antipsychotics (ATC N05A), Drug: Antidepressants (ATC N06A)Adults resident in the Local Health Authority of Bologna admitted to the emergency department after out-of-hospital cardiac arrest and discharged alive from hospital (ICD-9-CM 427.5). Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult residents of the Local Health Authority of Bologna, Italy, discharged alive after (1) an urgent hospital admission for trauma between 2014 and 2024, or (2) a hospital admission following out-of-hospital cardiac arrest.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Resident in the Local Health Authority of Bologna catchment area
- Trauma cohort: urgent ordinary-regime hospital admission with a discharge diagnosis in ICD-9-CM codes 800-999 and at least one injury with Abbreviated Injury Scale (AIS) severity of 1 or higher, between 2014 and 2024
- Cardiac arrest cohort: emergency department admission for out-of-hospital cardiac arrest with subsequent hospital discharge and ICD-9-CM code 427.5
- Residence and vital status confirmed on linkage to population records
Key exclusion criteria (2 listed)
- Death in hospital or within one day after discharge
- Non-resident or vital status not confirmable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioids (ATC N02A)Post-discharge outpatient dispensing of opioids (ATC N02A), as prescribed in routine care; exposure is observed, not assigned by the study. | Drug | Out-of-hospital cardiac arrest cohort, Trauma cohort |
| Antiepileptics (ATC N03A)Post-discharge outpatient dispensing of antiepileptics (ATC N03A, including gabapentinoids and clonazepam), as prescribed in routine care; exposure is observed, not assigned by the study. | Drug | Out-of-hospital cardiac arrest cohort, Trauma cohort |
| Antipsychotics (ATC N05A)Post-discharge outpatient dispensing of antipsychotics (ATC N05A), as prescribed in routine care; exposure is observed, not assigned by the study. | Drug | Out-of-hospital cardiac arrest cohort, Trauma cohort |
| Antidepressants (ATC N06A)Post-discharge outpatient dispensing of antidepressants (ATC N06A), as prescribed in routine care; exposure is observed, not assigned by the study. | Drug | Out-of-hospital cardiac arrest cohort, Trauma cohort |
Primary outcome
Percentage of Patients With Post-discharge Exposure to Each Psychoactive Drug Class
Time frame: 1 year after hospital discharge
Percentage of patients with at least one qualifying post-discharge treatment episode (treatment initiation, continuation, or restart within 30 days of discharge) for each drug class: opioids (ATC N02A), antiepileptics (N03A), antipsychotics (N05A), and antidepressants (N06A), derived from outpatient dispensing records and reported separately for each cohort.
Percentage of Exposed Patients by User Type for Each Psychoactive Drug Class
Time frame: 1 year after hospital discharge
Among patients exposed to each drug class (opioids, antiepileptics, antipsychotics, antidepressants) before admission and/or after discharge, percentage of naive users (exposure after discharge only), long-term users (exposure both before admission and after discharge), and interrupted users (exposure before admission only, not continued after discharge), reported separately for each cohort.
Percentage of New Users by Duration of Post-discharge Treatment for Each Psychoactive Drug Class
Time frame: 1 year after hospital discharge
Among naive users of each drug class (opioids, antiepileptics, antipsychotics, antidepressants), percentage whose qualifying post-discharge treatment episode lasted up to 30 days, 31-90 days, or 91-365 days (episode span, with dispensings chained using a 60-day grace period), reported separately for each cohort.
2 secondary outcomes
Number of low-acuity or incomplete emergency department visits
Time frame: 1 year after hospital discharge
Number of urgent hospital readmissions
Time frame: 1 year after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual patient data derive from regional administrative health databases and cannot be shared under Italian and EU data protection regulations; aggregated data and analysis code are available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Gamberini principal investigator
Azienda Usl di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Out-of-Hospital Cardiac Arrest, run by Azienda Usl di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Post-discharge Exposure to Each Psychoactive Drug Class (time frame: 1 year after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.